FDAnews
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MABTHERA RECOMMENDED FOR APPROVAL IN EUROPE

June 20, 2006

Swiss drugmaker Roche has announced that MabThera (rituximab) has received a recommendation for approval from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of rheumatoid arthritis (RA) in Europe. MabThera is the first and only selective B cell therapy. B cells play a key role in the chain of inflammatory events that ultimately lead to the damage of bone and cartilage in the joints, both serious outcomes characteristic of RA.

The announcement from the CHMP follows positive results from the Phase III REFLEX study, which showed that MabThera is a highly effective therapy for controlling symptoms in RA patients, providing lasting improvement after only two infusions per treatment course.